Hepatocellular Carcinoma (HCC)
Conditions
Interventions
Injection of HLA-A24- or -A2-restricted GPC3 peptide (EYILSLEEL or FVGEFFTDV) emulsified with Montanide ISA51 adjuvant. 3 mg intradermally injection, every 2 weeks. Tumor tissue biopsies after pe
Sponsors
Section for Cancer Immunotherapy, Investigative Treatment Division, Research Center for Innovative Oncology, National Cancer Center Hospital East
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Advanced HCC patient satisfying the following conditions, 1 Diagnosed as HCC 2 Age: 20-85 years old 3 ECOG performance status of 0-1 4 Child-Pugh A or B 5 Meet the following criteria for organ functions. 1. Neutrophil: more than 1,500/mm3 2. Hemoglobin: more than 8.0g/dL 3. Platelet: more than 50,000/mm3 4. Serum bilirubin: less than 3.0 mg/dL 5. Serum albumin: less than 2.8 g/dL 6. Serum AST/ALT: less than 150U/L 7. Serum creatinine: less than 1.5 mg/dL 6 HLA-A*24:02 or HLA-A*02:01, 02:06, 02:07 positive 7 Tumor tissue biopsy is practicable 8 At least 2 weeks since last therapy for HCC. 9 Written informed consent has been obtained.
Exclusion criteria
Exclusion criteria: 1. Uncontrolled pleural effusion or ascites 2. There are other malignancies 3. Active infection excluding HBV, HCV 4. Clinically significant heart disease (myocardial infarction or unstable angina within the past six months, or uncontrolled cardiac arrhythmias) 5. There are severe complications including cardiac failure, renal failure, liver failure, active gastro-duodenal ulcer, ileus, and uncontrolled Diabetes Mellitus 6. There is severe psychiatric disorder 7. Pregnant or lactating woman, who are willing to be pregnant 8. Past history of severe drug allergy 9. Past history of administration of GPC3 peptide vaccination 10. Responsible doctors judged the patient in appropriate for the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GPC3 peptide-specific immune-responses induced by GPC3 peptide vaccination. 1 Increase of frequency of GPC3-peptide specific CD8 positive T lymphocytes in the blood. 2 Increase of frequency of CD8 positive T lymphocytes into the tumor | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Progression : TTP Disease Control Rate : DCR Response Rate : RR Rate of 50% decreasing the level of serum tumor marker Rate of 50% decreasing the number of Circulating Tumor Cells(CTC) Adverse effects of GPC3 vaccination. Overall Survival : OS | — |
Countries
Japan
Contacts
Public ContactTetsuya Nakatsura
Research Center for Innovative Oncology, National Cancer Center Hospital East Section for Cancer Immunotherapy,
Outcome results
None listed